Study to Analyze the Risk Factors Associated With Pertussis/Whooping Cough Infection Among Infants

Completed

• Conditions: Tetanus; Acellular Pertussis; Diphtheria
• Interventions: Other: Retrospective database study using administrative claims data

• Registration Number: NCT01890850
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study aims to estimate the risk factors associated with pertussis/whopping cough infection among infants less than one year of age in a United States (U.S.) commercially insured population. The study will utilize a large research data base associated with a geographically diverse U.S. health plan not limited by one geographic area or disease outbreak to evaluate pertussis in infants between 2005 and 2010. Healthcare costs and utilization among infants with a reported diagnosis of pertussis/whooping cough stratified by the number of DTaP vaccinations received prior to infection will also be reported.

Detailed Description

This study will utilize the OptumInsight proprietary research database which contains enrollment and claims data for individuals enrolled in commercial health plans to estimate the measureable demographic, clinical and historical economic risk factors that may be associated with medically diagnosed pertussis/whooping cough infection among commercially insured infants less than one-year of age. Healthcare costs and utilization among infants with a reported diagnosis of pertussis/whooping cough will be stratified by the number of DTaP vaccinations received prior to infection.

Study Timeline

• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-06-27
• Study Start: 2013-07
• Study First Posted: 2013-07-02
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-20
• Last Update Posted: 2015-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Date of birth between July 1, 2005 and September 30, 2010.
• Enrollment in a commercial health plan within one month of birth.
• Known sex and geographic region.
• Infants will be included as a pertussis/whooping cough case if they meet the diagnosis criteria Infants not identified as a pertussis/whooping cough case are eligible for inclusion as a control.

Exclusion Criteria

• Enrollment does not include medical and pharmacy coverage.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	Retrospective database study using administrative claims data	Infants with no evidence of pertussis/whooping cough during within 12 months from birth (first year of life, between July 1, 2005 and September 30, 2010).
Pertussis Group	Retrospective database study using administrative claims data	Infants less than one year of age diagnosed with pertussis/whooping cough infection within 12 months from birth (first year of life, between July 1, 2005 and September 30, 2010).

Primary Outcome Measures

Name	Time	Method
Assessment of health care resource utilization	Up to one year	Health care resource utilization (e.g. ambulatory visits, emergency department visits, inpatient hospitalizations, length of stay) will be calculated for infants with a reported diagnosis of pertussis/whooping cough stratified by the number of DTaP vaccinations received prior to infection.
Assessment of health care costs	Up to one year	Health care costs will be computed as the combined health plan and patient paid amounts in the post-index period. Costs will be calculated as a total costs, medical costs, pharmacy costs, ambulatory costs, emergency costs and other costs and split by those occurring prior to the index date and those in the follow-up period. Costs will be adjusted to 2012 U.S. dollar values using the Medical Care Consumer Price Index.
Assessment of claim identified pertussis/whooping cough	Up to one year	The endpoint(s) for the primary objective are the odds ratios associated with factors modelled in a logistic regression (conditional logit model) where the outcome is the diagnosis of pertussis/whooping cough. Demographic, economic and clinical risk factors available in the administrative claims database and potentially associated with pertussis/whooping cough infection will be estimated. Covariates will be determined based on clinical rationale and statistical significance.